High-Flow Heated and Humidified Oxygen Therapy and Gastric Distension

NCT03134937 | Completed

• 1 other identifier: 17-5152
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

High Flow Heated and Humidified Nasal Oxygen therapy (HFHHNO) has been increasingly used in emergency medicine to assist patients with short term respiratory failure and to provide adequate oxygen to the body prior to intubation. Gastric distension which is the bloating of the stomach due to air being pumped into it is a concern for anesthesiologists as it increases the risk of nausea and vomiting during surgery (aspiration). The objective of this study is use an ultrasound machine to measure the volume of fluid in the stomach before and after HFNO is used in a standard clinical manner.

Conditions

Gastric Distention

Keywords

Gastric Ultrasound; Gastric Distension; Gastric Volume; Gastric Fluid Volume; High-flow oxygen therapy; HFHHNO; Healthy volunteer

Outcome Measures

Primary Outcomes (1)

• Change in Gastric Volume

  Ultrasound scan will be used to determine if there was an increase in gastric fluid volume following session of oxygen therapy.

  Prior to, and immediately following session of HFHHNO oxygen therapy.

Secondary Outcomes (1)

• Gastric Distension

  Immediately following session of HFHHNO oxygen therapy.

Study Arms (1)

Study Arm

OTHER

Participants will undergo one session of high-flow heated and humidified oxygen therapy (HFHHNO) (up to 60-70 litre/min). They will undergo a gastric ultrasound scan after session of HFHHNO therapy.

Device: High-Flow Heated and Humidified Oxygen Therapy (HFHHNO)

Interventions

High-Flow Heated and Humidified Oxygen Therapy (HFHHNO) DEVICE

Participants will undergo one session of high-flow heated and humidified oxygen therapy (HFHHNO) (up to 60-70 litre/min). They will undergo a gastric ultrasound scan after session of HFHHNO therapy.

Study Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy volunteers aged 18 to 70 years
• Male or female
• American Society of Anesthesia physical status classification I and II
• Height greater than 145 cm
• Ability to understand the study protocol and provide informed consent. Communication difficulties will not be an impediment to participate. In case of a language barrier, translation services will be sought as per usual institutional practice.

You may not qualify if:

• Subjects predisposed to have an increased residual gastric volume at baseline (e.g. diabetes or known gastric dysmotility)
• History of major upper gastrointestinal disease (including hiatus hernia or prior gastroduodenal surgery)
• Morbid obesity (Body Mass Index \> 40 Kg/m2)
• Chronic Obstructive Pulmonary Disease (Emphysema or Chronic Bronchitis)
• Subjects diagnosed with type I and II Diabetes

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Kaiser Permanente: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

Related Publications (1)

• McLellan E, Lam K, Behringer E, Chan V, Bozak D, Mitsakakis N, Perlas A. High-flow nasal oxygen does not increase the volume of gastric secretions during spontaneous ventilation. Br J Anaesth. 2020 Jul;125(1):e75-e80. doi: 10.1016/j.bja.2020.02.023. Epub 2020 Mar 31.

  PMID: 32241548 DERIVED

Study Officials

• Anahi Perlas, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Every participant will recieve one HFHHNO session, will get 30 mins of oxygen up to 60-70 L/min.

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: May 1, 2017
• Study Start: November 6, 2017
• Primary Completion: March 20, 2019
• Study Completion: March 20, 2019
• Last Updated: September 10, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)